Surgical Warming Blankets to Blame for Multiple Post-Operative Infections – Who is at Fault?

For some time now, there have been a plethora of reports about the Bair Hugger surgical warming blankets manufactured by 3M. The federal courts originally accepted the case as a multi-district litigation suit. At that time, there were just over a dozen patient complaints.

Now, the numbers have escalated dramatically, with more than 900 cases of plaintiffs claiming that the Bair Hugger warming blanket led to a surgical site infection.

The Issue with the Bair Hugger Blanket

The way the Bair Hugger warming blanket works is the issue. While it has been widely accepted and heavily used in the medical industry, the warming blanket is now being blamed for infections. The Bair Hugger works by forcing warm air into a sterile disposable blanket that is placed on top of a patient during surgery.

This keeps the patient warm while undergoing the surgical procedure, but the lawsuit alleges that the portion of the device that forces air into the disposable blankets could be contaminated, because the device sits on the surgical suite floor. Therefore, the contamination increases the risk for surgical site infections when the air being trapped and circulated by the device is exposed and sending air to the blankets on the patient.

Surgical site infections are the main reason for this complaint against 3M. While this case is ongoing, any patient who receives a surgical procedure and suffers from a postoperative infection should be aware of his or her rights.

3M is the manufacturer of the medical device in question, which is why it is named in the lawsuit. 3M is a leading manufacturer of medical equipment, so it is the party named in the lawsuit instead of the physicians who performed the surgeries or used the products.

The reason for this is that these blankets are widely accepted by the medical community; therefore, doctors had no reason to think that they were a threat for postoperative infections. The manufacturer, however, had been told about the danger of infections for the past few years, and it did not notify physicians or hospitals that were using the devices. By failing to warn the public, 3M is now liable under product liability.

What is a Surgical Site or Postoperative Infection?

Surgical site infections are those that occur where the surgery took place. They can affect the incision or the organs that were involved in the surgery. Typically, the human body’s skin layers protect it from infection, but after that skin is cut, it exposes the organs and tissues to foreign materials (including bacteria).

There are different types of surgical site infections (SSIs). Usually, these occur within a 30-day period after the procedure, and can include:

Superficial Incisional SSI – This is an infection on the upper area of the skin where the incision was made – it does not penetrate the tissues deeply.

Deep Incisional SSI – The infection in this case is into the muscle and tissues around the muscle.

Organ and Space SSI – Any area of the body, excluding the skin, is infected – including muscles and tissues involved in the surgery. Organs and spaces in between organs are infected, as well.

What Increases the Risk of an SSI?

Any infection that happens post-surgery are caused by germs. The most common are bacteria like Pseudomonas, Streptococcus, and Staphylococcus. These germs infect the surgical site through direct contact, such as a contaminated glove on a surgeon, the air, or through germs on the body that were not properly disinfected prior to surgery.

Surgical wounds and SSI risks are based on the type of wound the patient has, and are categorized by:

Clean Wounds – Clean wounds are not inflamed or contaminated, and the site did not involve operating on a human organ.

Clean Contaminated Wounds – There is no evidence of infection at the time of the procedure, but the site was an internal organ.

Contaminated Wounds – When an operation is done on an internal organ, and contents have spilled from that organ into the wound.

Dirty Wounds – Wounds have an infection, the surgeon is aware of the infection, and the infection is present at the time of the procedure.

There are other risk factors that can increase the likelihood that a patient has an SSI, including:

Surgical procedures lasting more than two hours.

Having a medical problem or chronic illness.

Being over the age of 65.

Being overweight.

Being a smoker or heavy drinker.

Suffering from a weak immune system or a disease, like cancer.

Having emergency surgery or abdominal procedures.

Also, postoperative care is critical, because how a patient and the caregiver handles the surgical site could determine if there is an infection. Washing hands with soap and water and keeping the surgical site clean is one of the best defenses to an SSI.

How Does a Patient Know He or She Has an SSI?

Most of the time, a patient or caregiver will recognize the signs of an SSI before it becomes serious. The SSI typically presents itself with inflamed, red skin. The scar may take longer to heal, may be tender, and may even have swelling or a sensation of warmth to the touch. A fever and pain may also be associated with the SSI.

Superficial SSIs typically ooze and drain, so a physician will culture the site to see what infection the patient might have. Deep incisional SSIs also produce pus, and the wound may open back up on its own or a surgeon may open the wound to find the infection.

Organ and space SSIs are the most dangerous, and they will have a drain placed under the skin to help remove fluids. If that drain shows evidence of pus, the physician may perform scans and tests to find what infection the patient has contracted.

Once a patient is diagnosed with an SSI, the physician will prescribe a course of antibiotics. However, severe SSIs could result in another surgery to remove infected tissues, and in some cases, SSIs can turn to sepsis – a life-threatening infection.

SSIs and Product Liability

In the Bair Hugger case, the SSIs were the result of a defective product; not the physician’s or hospital’s negligence. The surgeons using the blankets, as well as the hospitals that purchased them, did not know there was a risk for postoperative infections.

The manufacturer, under product liability law, is required to ensure that products are safe. Manufacturers are held to a higher standard, and if there is a foreseeable harm from their products, the law requires them to warn the public or remove the product from distribution.

3M was aware of the risk for an SSI by using Bair Hugger blankets, but it failed to warn physicians or take steps to prevent SSIs from the device. By failing to do so, it could be held liable under product liability laws.

SSIs and Physician or Healthcare Provider Liability

SSIs may not always be the result of contaminated medical equipment. Sometimes, doctors and surgical staff are liable for a patient’s postoperative infection. For example, a physician who fails to wash his or her hands properly before the surgery could inadvertently contaminate the patient’s surgical site.

If the staff supplying the surgical suite with equipment does not properly sanitize or handle the equipment for that surgery, they could allow contamination to occur, resulting in a postoperative infection.

What About the Hospital or Surgical Center?

Sometimes, the liability falls on the surgical center or hospital through vicarious liability or the hospital’s outright negligence.

For example, a hospital may know that its equipment used to sanitize surgical items is faulty. However, the facility chose to use the device for sanitizing anyway. As a result, several patients suffered from an infection. In this case, the hospital’s negligence and failure to replace or stop surgeries until the faulty unit was replaced caused patient infections.

Under vicarious liability, the hospital could be liable for the actions of its staff. So, if a nurse or physician was responsible for the patient’s surgical site infection, the hospital could be named in the suit as his or her employer. However, under vicarious liability, the hospital would only be liable if the health care worker was considered an “employee” of that hospital, and if that employee was operating within his or her normal employment duties. If a physician was treating a patient in-home, outside of his or her duties to the hospital, and that patient develops a surgical site infection, the hospital is unlikely to be considered a liable party.

Not All Surgical Site Infections Are Result of Negligence

Doctors, hospitals, and even manufacturers of medical devices are only liable for surgical site infections that are a result of negligence. Not all infections post-operation are the result of negligence.

A postoperative infection can happen to any patient, even to a patient who does not have risk for an SSI. If a patient does not follow wound care instructions from his or her surgeon or fails to take antibiotics, the developed infection would likely be from the patient’s own doing – not the negligence of a healthcare provider.

Other times, the patient and the physician do everything right, and an infection occurs anyway. Without the presence of negligence, there is no basis for a malpractice lawsuit against the surgeon or hospital where the surgery was performed.

Did You Suffer a Surgical Site Infection? Contact a Medical Malpractice Attorney

If you have suffered from an SSI, you could face additional medical costs, longer recovery times, more time away from work, and life-threatening conditions in the aftermath.

If you suspect that your SSI is the result of a physician’s, medical device manufacturer’s, or hospital’s negligence, you must contact a malpractice attorney immediately. A personal injury lawyer can review the facts of your case, go over medical records, and determine if your SSI was likely the cause of someone’s negligence.

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Wednesday, July 27, 2016

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